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FDA Orders Label Warning for Testosterone Gels
Date:5/7/2009

ced a range of adverse side effects as a result of coming into direct and repeated contact with the treated skin of an adult user of either gel.

This type of exposure triggered "inappropriate virilization" among the young patients, Murphy said, including the onset of premature male characteristics in boys and inappropriate male characteristics among girls. The effects included "inappropriate enlargement of the penis or clitoris, premature development of pubic hair, advanced bone age, increased libido, and aggressive behavior" among the eight cases analyzed, Murphy said.

In most cases, these side effects subsided after exposure ceased, the FDA said, but in certain instances, genitalia enlargement and bone age did not revert to normal. As well, some children had to undergo invasive diagnostic procedures, while in one of the eight cases, hospitalization and surgical intervention was required.

"In the cases we reviewed, the average duration of exposure was around six months to a year" before the children received medical attention, noted Dr. Mary Roberts, a medical officer in the division of metabolism and endocrinology within the FDA's Office of New Drugs, Center for Drug Evaluation and Research (CDER). "We can't tell you if it lasted for five minutes or five hours, but we do know the exposure did occur over a period of time."

Murphy and her colleagues hope the new labeling requirement will encourage consumers to more closely follow the approved protocol for the use of such gels. These include avoiding application of the drugs to parts of the body not indicated as appropriate; washing hands with soap and water after every application; and covering the application site with clothing once dry.

And they added that women should not use either gel, despite the fact the agency found that about 25,000 of the AndroGel prescriptions in 2007 were, in fact, dispensed to women.

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FDA Orders Label Warning for Testosterone Gels
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